BEUDAMED
    FDA Recall Terminated

    POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08

    Recall: Z-1805-2009 · Initiated June 17, 2009

    Recall

    Recall Number
    Z-1805-2009
    Event Number
    52705
    Firm
    Abbott Vascular-Cardiac Therapies dba Guidant Corporation
    FEI Number
    2024168
    Product Code
    MAF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 17, 2009
    Posted
    July 29, 2009
    Terminated
    July 6, 2010
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08

    Reason

    Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.

    Action

    Abbott Vascular sent an Urgent Device Recall letter (w/return form) to customers on June 17, 2009 requesting return of identified products to Abbott Vascular Territory Manager. Abbott Vascular issued a press release dated July 28, 2009.

    Distribution

    Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom.

    Quantity

    557 total devices